Novosom AG acquires exclusive license from Isis Pharmaceuticals, Inc. for CD40-targeted antisense inhibitors

Novosom today announced that it has acquired an exclusive, worldwide license from Isis Pharmaceuticals to access certain antisense inhibitors targeting CD40 mRNA for a number of indications

Halle, Germany | August 26, 2008 | Novosom AG today announced that it has acquired an exclusive, worldwide license from Isis Pharmaceuticals to access certain antisense inhibitors targeting CD40 mRNA for a number of indications. This deal exercises an option agreement signed in February 2007 between the two companies and provides novosom AG with exclusive, worldwide and sub-licensable access to certain of Isis’ proprietary antisense oligonucleotides targeting CD40 as well as a non-exclusive worldwide and sub-licensable access to certain aspects of Isis’ core technology patents. This includes the second generation antisense chemistry, specifically 2' MOE oligonucleotides for these inhibitors. In return, Isis will receive financial considerations including an upfront exercise fee, milestone payments and royalties.

Novosom plans to target CD40, a well established target for both inflammatory diseases and B-cell cancers, for indications such as Crohn's disease, organ transplant or rheumatoid arthritis. Novosom will use its proprietary Smarticles(R) technology to enhance the systemic delivery of antisense targeting CD40. Compared to the anti-inflammatory blockbuster Remicade, this encapsulated antisense approach has demonstrated targeted delivery to specific cell types with a rapid onset of action and superior in vivo efficacy.

Elias Papatheodorou, CEO of novosom AG, commented: “This license deal marks a very important milestone for novosom AG in antisense drug development. It follows two other important milestones: this year’s successful IND and the granting of our umbrella patents for the Smarticles(R) siRNA and antisense delivery technology in the US and EU. We are also excited to be working with Isis’ antisense 2’ MOE chemistry for CD40 inhibitors. This, complemented with our Smarticles(R) delivery technology, is showing tremendous promise in animal models of multiple inflammatory diseases.”

Dr. Steffen Panzner, Founder and CSO of novosom AG, added: “The preclinical data set is exciting in terms of efficacy and tolerability and we look very much forward to bringing this oligonucleotide/delivery combination into the drug development process. This will be the second systemically delivered oligonucleotide drug using our Smarticles(R) technology to enter the clinic. Our agreement with Isis Pharmaceuticals allows us to further expand the current established safety and efficacy of our Smarticles(R) delivery platform.”

“We are pleased to have novosom as a partner in advancing our antisense CD40 inhibitors,” said Dr. Frank Bennett, Isis Senior Vice President of Research. “Novosom is pioneering a new combination of Smarticles(R) with antisense inhibitors to CD40 which will add another novel drug to our pipeline of promising antisense drugs that target a broad range of diseases. We look forward to further collaborating with novosom on the development of CD40 antisense oligonucleotides.”
About Novosom AG

Novosom is working with its partners to develop unique antisense, DNAi and siRNA based therapeutics with a current focus in inflammation, oncology and liver diseases. Novosom's Smarticles(R) liposomal vectors allow partners to deliver their active substance (siRNA, antisense, decoy etc) inside the cell either for topical or systemic applications. The Company filed a successful IND with its partner ProNAi Therapeutics in the field of oncology. Novosom AG main investors include IBG Beteiligungsgesellschaft Sachsen-Anhalt mbH and MBG Mittelständische Beteiligungsgesellschaft Sachsen Anhalt as well as private Investors.

About CD40

CD40 is a membrane protein that is expressed on the antigen presenting cells (APCs) and facilitates integration of feedback signals from T cells via CD154 and danger signals from Toll-like receptors sitting on the APCs. Such signal integration is key to refine the antigen presentation and results in a straightforward immune response.

Novosom’s Smarticles(R) / CD40 antisense combination has achieved targeted delivery that is specific to APCs.

About Smarticles (R)

Novosom’s Smarticles (R) are a pioneering, fully charge-reversible liposomal technology for the delivery of siRNA, antisense, DNAi or other oligonucleotides inside the cell. Smarticles(R) are an enabler for the use of such oligonucleotides in systemic treatments. Novosom has data with both single stranded and double stranded oligonucleotide technologies in rheumatoid arthritis, inflammatory bowel disease (IBD), transplants, liver diseases, and xenograft oncology models.

SOURCE: Novosom AG

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